39CLINICAL STUDIES RANDOMIZED CONTROLLED CLINICAL TRIALS
Figure 14 Mean (95% CI) change from baseline in WOMAC A (knee pain subscale) versus study day.
Ch an
ge fr
om b
as el
in e
(m m
)
1
Traumeel® and Zeel®T N = 117
Placebo N = 111
* p<0.05
8 15 29 43 57 71 85 99 0
-5
-10
-15
-20
-25
-30
-35
injections 2nd 3rd1st
Study day
*
* * * * *
Figure 15 Percentage of patients who met MCII threshold for clinically relevant WOMAC A (Knee Pain Subscale) improvement at end-of-study compared to baseline.
Pe rc
en ta
ge o
f p at
ie nt
s w
ho m
et V
A S
pa in
M
CI I c
ri te
ri on
o f -
36 .6
m m
1
60
-50
-40
-30
-20
-10
-0 Traumeel® and Zeel® T
n = 117
Placebo n = 111
p<0.0054
Results Treatment arms were well balanced across demographic and baseline
characteristics. Primary endpoint The primary endpoint demonstrated that mean (SD) change in knee pain (mm)
from baseline (Day 1, pre-dose) to end-of-study (Day 99) was -32.0 (26.88) in the Traumeel® and Zeel® T and -25.5 (24.08) in the saline group; the difference was statistically significant, favoring Traumeel® and Zeel® T (p=0.0383, 95% CI for difference: -12.40, -0.35). At all visits, mean pain (WOMAC A Pain) decrease was higher in
Traumeel® and Zeel® T than in the saline group. Differences between treatment groups were statistically significant (p<0.05) at all visits except Days 8 and 29 (Figure 14).
In the post-hoc analysis, 57/117 (48.7%) patients treated with IA Traumeel® and Zeel® T met the MCII criterion for clinical relevance, compared with 36/111 (32.4%) patients with IA placebo (p=0.0054) (Figure 15).
